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Vaginal Tactile Imager for Pelvic Floor Biomechanical Assessment

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2SB1AG034714-06
Agency Tracking Number: SB1AG034714
Amount: $1,183,791.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: N
Solicitation Number: PAR16-027
Timeline
Solicitation Year: 2016
Award Year: 2016
Award Start Date (Proposal Award Date): 2016-08-15
Award End Date (Contract End Date): 2019-05-31
Small Business Information
1457 LOWER FERRY RD
Trenton, NJ 08618-1453
United States
DUNS: 959147026
HUBZone Owned: No
Woman Owned: Yes
Socially and Economically Disadvantaged: No
Principal Investigator
 NOUNE SARVAZYAN
 (609) 433-1300
 nsarvaz@artannlabs.com
Business Contact
 NOUNE SARVAZYAN
Phone: (512) 996-8565
Email: nsarvaz@artannlabs.com
Research Institution
N/A
Abstract

Pelvic organ prolapse POP is a highly prevalent condition affecting over of women in the
US during their lifetimes Urinary incontinence UI affects an estimated of women Both
POP and UI are more common in women than in men and their prevalence is increased with
age Some loss of utero vaginal support occurs in most adult women however the true etiology
of prolapse and differences seen among individuals are not entirely understood Changes in the
elasticity of the vaginal walls connective support tissues and muscle function are thought to be
significant factors in the development of the diseased conditions There is a strong need in
pelvic floor structure and functional imaging to be integrated into mainstream diagnostics in
obstetrics gynecology and urogynecology This integration will facilitate communications
between different specialties and has the potential to greatly improve the multidisciplinary
management of complex pelvic floor disorders In the Phases I IIB of this project we developed
an innovative approach and the device Vaginal Tactile Imager VTI completed clinical
studies received an FDA approval for the core technology and established manufacturing and
distribution partnership with Advanced Tactile Imaging www tactile imaging com These were
the critical steps that significantly reduced number of project risk factors However crossing the
Valley of Death to make this innovative device commercially successful requires additional
support in technical assistance as well as in later stage research and development We
identified and proposed how to overcome four critical barriers to commercial success need
for reimbursement CPT codes high manufacturing cost additional clinical evidence of
VTI capabilities in diagnosis and aid for choice of applied treatment and FDA clearance for
clinically relevant Indication for Use Removing these obstacles would lead to clinical
acceptance and market penetration of this new technology Pelvic organ prolapse urinary incontinence and other pelvic diseased conditions affect over
of women in the US during their lifetimes Prevalence of these conditions is increased with
age Some loss of utero vaginal support occurs in most adult women however the true etiology
of prolapse and differences seen among individuals are not entirely understood It impairs the
quality of life and results in over surgical procedures annually in the US The goal of
this project is to develop Vaginal Tactile Imager VTI for real time elasticity imaging
quantitative characterization of pelvic floor support structures and muscle function The VTI has
the potential to predict risk of developing diseased conditions aid in diagnosis monitoring and
individually optimized treatment

* Information listed above is at the time of submission. *

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